Lithium Drug-Drug Interaction Study With Lurasidone HCl

• ClinicalTrials.gov Identifier: NCT01074073
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Last Update Posted: September 8, 2011
• Sponsor: Sunovion
• Information provided by (Responsible Party): Sunovion

Study Description

Brief Summary:

The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Lurasidone HCl	Phase 1

Detailed Description:

To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder
• Study Start Date: August 2008
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: October 2008

Arms and Interventions

Arm

Intervention/treatment

Lithium/Lurasidone; Schizophrenia Patients

Drug: Lurasidone HCl; lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD). Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID). On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast.

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.

2. Females who participate in this study:

   • are unable to have children-OR-
   • are willing to remain abstinent from Day -5 until 90 days after discharge;
3. Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

1. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
2. Positive test results within 30 days prior to the start of the study for:
3. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
4. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
5. Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
6. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.

Contacts and Locations

Locations

United States, California

CCT/Parexel

Culver City, California, United States, 90232

Sponsors and Collaborators

Sunovion

Investigators

• Principal Investigator: Marina Bussel, MD; CCT/Parexel

More Information

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01074073
• Other Study ID Numbers: D1050247
• First Posted: February 24, 2010
• Last Update Posted: September 8, 2011
• Last Verified: September 2011

Keywords provided by Sunovion:

Lithium DDI with Lurasidone HCl; Male/Female, Schizophrenia Patients

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Lurasidone Hydrochloride; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Adrenergic alpha-2 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents